Rule 424(b)(3)
File #333-151667
PROSPECTUS SUPPLEMENT
(to Prospectus dated July 10, 2008)
CEL-SCI CORPORATION
Common Stock
Effective March 6, 2009, CEL-SCI Corporation entered into a licensing
agreement with Byron Biopharma LLC ("Byron") under which CEL-SCI granted Byron
an exclusive license to market and distribute CEL-SCI's cancer drug Multikine(R)
in the Republic of South Africa.
Pursuant to the agreement, Byron will be responsible for registering the
product in South Africa. Once Multikine has been approved for sale, CEL-SCI will
be responsible for manufacturing the product, while Byron will be responsible
for sales in South Africa. Revenues will be divided equally between CEL-SCI and
Byron. To maintain the license Byron, among other requirements, must make
milestone payments to CEL-SCI totaling $125,000 on or before March 15, 2010.
On March 27, 2009, and as further consideration for its rights under the
licensing agreement, Byron Biopharma purchased 3,750,000 Units from CEL-SCI at a
price of $0.20 per Unit. Each Unit consisted of one share of CEL-SCI's common
stock and two warrants. Each warrant entitles the holder to purchase one share
of CEL-SCI's common stock at a price of $0.25 per share. The warrants will be
exercisable at any time after September 8, 2009 and prior to March 6, 2016. The
shares of common stock and warrants included as a component of the Units are
being offered by means of this prospectus. CEL-SCI will file a new registration
statement to register the shares issuable upon the exercise of the warrants.
The securities sold by this prospectus supplement are speculative and
involve a high degree of risk and should be purchased only by persons who can
afford to lose their entire investment. For a description of certain important
factors that should be considered by prospective investors, see "Risk Factors"
beginning on page 4 of the accompanying prospectus.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or has passed upon
the accuracy or adequacy of this prospectus. Any representation to the contrary
is a criminal offense.
CEL-SCI's common stock is traded on the NYSE AMEX under the symbol "CVM".
On March 27, 2009 the closing price of CEL-SCI's common stock was $0.26.
The date of this prospectus supplement is March 27, 2009
1
PROSPECTUS SUMMARY
THIS SUMMARY IS QUALIFIED BY THE MORE DETAILED INFORMATION APPEARING ELSEWHERE
IN THIS PROSPECTUS SUPPLEMENT, AS WELL AS THE ACCOMPANYING PROSPECTUS DATED JULY
10, 2008.
Forward Looking Statements
This prospectus contains various forward-looking statements that are based
on CEL-SCI's beliefs as well as assumptions made by and information currently
available to CEL-SCI. When used in this prospectus, the words "believe",
"expect", "anticipate", "estimate" and similar expressions are intended to
identify forward-looking statements. Such statements may include statements
regarding CEL-SCI's research and development projects, and are subject to
certain risks, uncertainties and assumptions which could cause actual results to
differ materially from projections or estimates. Factors which could cause
actual results to differ materially are discussed at length under the heading
"Risk Factors" in the accompanying prospectus dated July 10, 2008. Should one or
more of the enumerated risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
anticipated, estimated or projected. Investors should not place undue reliance
on forward-looking statements, all of which speak only as of the date made.
CEL-SCI
-------
CEL-SCI Corporation (CEL-SCI) was formed as a Colorado corporation in
1983. CEL-SCI's principal office is located at 8229 Boone Boulevard, Suite 802,
Vienna, VA 22182. CEL-SCI's telephone number is 703-506-9460 and its web site is
www.cel-sci.com. CEL-SCI makes its electronic filings with the Securities and
Exchange Commission (SEC), including its annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K and amendments to these
reports available on its website free of charge as soon as practicable after
they are filed or furnished to the SEC.
MULTIKINE
---------
CEL-SCI's lead product, Multikine(R), is being developed for the treatment
of cancer. It is the first of a new class of cancer immunotherapy drugs called
Immune SIMULATORs. It simulates the activities of a healthy person's immune
system, which battles cancer every day. Multikine is multi-targeted; it is the
only cancer immunotherapy that both kills cancer cells in a targeted fashion and
activates the general immune system to destroy the cancer. We believe Multikine
is the first immunotherapeutic agent being developed as a first-line standard of
care treatment for cancer and it is cleared for a global Phase III clinical
trial in advanced primary (previously untreated) head and neck cancer patients.
Multikine is a new type of immunotherapy in that it is a comprehensive
immunotherapy, incorporating both active and passive immune activity. A
comprehensive immunotherapy most closely resembles the workings of the natural
immune system in the sense that it works on multiple fronts in the battle
against cancer. A comprehensive immunotherapy causes a direct and targeted
2
killing of the tumor cells and activates the immune system to produce a more
robust and sustainable anti-tumor response.
Multikine is designed to target the tumor micro-metastases that are mostly
responsible for treatment failure. The basic concept is to add Multikine to the
current cancer treatments with the goal of making the overall cancer treatment
more successful. Phase II data indicated that Multikine treatment resulted in a
substantial increase in the survival of patients. The lead indication is
advanced primary (previously untreated) head & neck cancer (about 600,000 new
cases per annum). Since Multikine is not tumor specific, it may also be
applicable in many other solid tumors.
In January 2007, the US Food and Drug Administration (FDA) concurred with
the initiation of a global Phase III clinical trial in head and neck cancer
patients using Multikine. The Canadian regulatory agency, the Biologics and
Genetic Therapies Directorate, had previously concurred with the initiation of a
global Phase III clinical trial in head and neck cancer patients using
Multikine.
The protocol is designed to develop conclusive evidence of the efficacy of
Multikine in the treatment of advanced primary (previously untreated) squamous
cell carcinoma of the oral cavity (head and neck cancer). A successful outcome
from this trial should enable CEL-SCI to apply for a Biologics License to market
Multikine for the treatment of this patient population.
The trial will test the hypothesis that Multikine treatment administered
prior to the current standard therapy for head and neck cancer patients
(surgical resection of the tumor and involved lymph nodes followed by
radiotherapy or radiotherapy and concurrent chemotherapy) will extend the
overall survival, enhance the local/regional control of the disease and reduce
the rate of disease progression in patients with advanced oral squamous cell
carcinoma.
L.E.A.P.S.
----------
CEL-SCI's patented T-cell Modulation Process uses "heteroconjugates" to
direct the body to choose a specific immune response. The heteroconjugate
technology, referred to as L.E.A.P.S. (Ligand Epitope Antigen Presentation
System), is intended to selectively stimulate the human immune system to more
effectively fight bacterial, viral and parasitic infections as well as
autoimmune, allergies, transplantation rejection and cancer, when it cannot do
so on its own. Administered like vaccines, L.E.A.P.S. combines T-cell binding
ligands with small, disease associated, peptide antigens and may provide a new
method to treat and prevent certain diseases.
The ability to generate a specific immune response is important because
many diseases are often not combated effectively due to the body's selection of
the "inappropriate" immune response. The capability to specifically reprogram an
immune response may offer a more effective approach than existing vaccines and
drugs in attacking an underlying disease.
Using the LEAPS technology, CEL-SCI discovered a peptide, named CEL-1000,
which is currently being tested in animals for the prevention/treatment of avian
flu, herpes simplex, malaria, viral encephalitis, smallpox, vaccinia and a
number of other indications.
3
CEL-SCI has funded the costs associated with the clinical trials relating
to CEL-SCI's technologies, research expenditures and CEL-SCI's administrative
expenses with the public and private sales of CEL-SCI's securities and
borrowings from third parties, including affiliates of CEL-SCI.
All of CEL-SCI's products are in the development stage. As of March 30,
2008 CEL-SCI was not receiving any revenues from the sale of MULTIKINE or any
other products which CEL-SCI was developing.
CEL-SCI does not expect to develop commercial products for several years,
if at all. CEL-SCI has had operating losses since its inception, had an
accumulated deficit of approximately $(127,000,000) at December 31, 2008 and
expects to incur substantial losses for the foreseeable future.
CEL-SCI's executive offices are located at 8229 Boone Blvd., #802, Vienna,
Virginia 22182, and its telephone number is (703) 506-9460.
THE OFFERING
Securities Offered: 3,750,000 Units at a price of $0.20 per Unit. Each Unit
consists of one share of CEL-SCI's common stock and two
warrants. Each warrant entitles the holder to purchase
one share of CEL-SCI's common stock at a price of $0.25
per share. The warrants will be exercisable at any time
after September 8, 2009 and prior to March 6, 2016.
The shares of common stock and warrants included as a
component of the Units are being offered by means of
this prospectus. CEL-SCI will file a new registration
statement to register the shares issuable upon the
exercise of the warrants.
Risk Factors: The purchase of the securities offered by this
prospectus involves a high degree of risk. Risk factors
include the lack of revenues and history of loss, need
for additional capital and need for FDA approval. See
the "Risk Factors" section of the accompanying
prospectus.
NYSE AMEX Symbol: CVM
Use of Proceeds: The net proceeds from the sale of the securities
offered, after deducting estimated expenses
of this offering, will be approximately $740,000 and
will be used for CEL-SCI's general and administrative
expenses, research and clinical trials.
4
PLAN OF DISTRIBUTION
This prospectus pertains to sales of CEL-SCI's common stock to Byron
Biopharma LLC.
CEL-SCI will not receive any proceeds from the sale of the shares by Byron
Biopharma. Byron Biopharma may resell the shares it acquires by means of this
prospectus from time to time in the public market. The costs of registering the
shares sold to Byron Biopharma is being paid by CEL-SCI. Byron Biopharma will
pay all other costs pertaining to the sale of its shares.
Manner of Sale.
The 3,750,000 shares of common stock owned by Byron Biopharma, may be
offered and sold by Byron Biopharma from time to time as market conditions
permit in the over-the-counter market, or otherwise, at prices and terms then
prevailing or at prices related to the then-current market price, or in
negotiated transactions. These shares may be sold by one or more of the
following methods, without limitation:
o a block trade in which a broker or dealer so engaged will attempt to
sell the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
o purchases by a broker or dealer as principal and resale by such broker
or dealer for its account pursuant to this prospectus;
o ordinary brokerage transactions and transactions in which the broker
solicits purchasers; and
o face-to-face transactions between sellers and purchasers without a
broker/dealer.
When making sales, brokers or dealers engaged by Byron Biopharma may
arrange for other brokers or dealers to participate. These brokers or dealers
may receive commissions or discounts from Byron Biopharma in amounts to be
negotiated.
Byron Biopharma is an "underwriter" and any broker/dealers who act in
connection with the sale of the shares by Byron Biopharma may be deemed to be
"underwriters" within the meaning of Section 2(11) of the Securities Acts of
1933, and any commissions received by them and profit on any resale of the
shares as principal might be deemed to be underwriting discounts and commissions
under the Securities Act.
CEL-SCI has advised Byron Biopharma, and any securities broker/dealers or
others who sell CEL-SCI's shares on behalf of Byron Biopharma, that they may be
deemed to be statutory underwriters. CEL-SCI has also advised Byron Biopharma
that in the event of a "distribution" of its shares Byron Biopharma, any
"affiliated purchasers", and any broker/dealer or other person who participates
in such distribution may be subject to Rule 102 under the Securities Exchange
Act of 1934 ("1934 Act") until their participation in that distribution is
completed. Rule 102 makes it unlawful for any person who is participating in a
5
distribution to bid for or purchase stock of the same class as is the subject of
the distribution. A "distribution" is defined in Rule 102 as an offering of
securities "that is distinguished from ordinary trading transactions by the
magnitude of the offering and the presence of special selling efforts and
selling methods". CEL-SCI has also advised Byron Biopharma that Rule 101 under
the 1934 Act prohibits any "stabilizing bid" or "stabilizing purchase" for the
purpose of pegging, fixing or stabilizing the price of the common stock in
connection with the distribution of its shares.
The shares of CEL-SCI's common stock which may be sold to Byron Biopharma
have been registered with the Securities and Exchange Commission to enable Byron
Biopharma to sell the common stock in the public market. However, CEL-SCI has no
obligation:
o to assist or cooperate with Byron Biopharma in the offering or
disposition of its shares;
o to obtain a commitment from an underwriter relative to the sale of any
its shares; or
o to include the shares within any underwritten offering.
DESCRIPTION OF SECURITIES
Common Stock
------------
CEL-SCI is authorized to issue 300,000,000 shares of common stock, (the
"common stock"). Holders of common stock are each entitled to cast one vote for
each share held of record on all matters presented to shareholders. Cumulative
voting is not allowed; hence, the holders of a majority of the outstanding
common stock can elect all directors.
Holders of common stock are entitled to receive such dividends as may be
declared by the Board of Directors out of funds legally available therefor and,
in the event of liquidation, to share pro rata in any distribution of CEL-SCI's
assets after payment of liabilities. The board is not obligated to declare a
dividend. It is not anticipated that dividends will be paid in the foreseeable
future.
Holders of common stock do not have preemptive rights to subscribe to
additional shares if issued by CEL-SCI. There are no conversion, redemption,
sinking fund or similar provisions regarding the common stock. All of the
outstanding shares of common stock are fully paid and non-assessable and all of
the shares of common stock offered as a component of the Units will be, upon
issuance, fully paid and non-assessable.
Preferred Stock
---------------
CEL-SCI is authorized to issue up to 100,000 shares of preferred stock.
CEL-SCI's Articles of Incorporation provide that its Board of Directors has the
authority to divide the preferred stock into series and, within the limitations
provided by Colorado statute, to fix by resolution the voting power,
designations, preferences, and relative participation, special rights, and the
6
qualifications, limitations or restrictions of the shares of any series so
established. As CEL-SCI's Board of Directors has authority to establish the
terms of, and to issue, the preferred stock without shareholder approval, the
preferred stock could be issued to defend against any attempted takeover of
CEL-SCI.
ADDITIONAL INFORMATION
CEL-SCI is subject to the requirements of the Securities Exchange Act of
l934 and is required to file reports, proxy statements and other information
with the Securities and Exchange Commission. Copies of any such reports, proxy
statements and other information filed by CEL-SCI can be read and copied at the
Commission's Public Reference Room at 100 F. Street, N.E., Washington, D.C.
20549. The public may obtain information on the operation of the Public
Reference Room by calling the Commission at 1-800-SEC-0330. The Commission
maintains an Internet site that contains reports, proxy and information
statements, and other information regarding CEL-SCI. The address of that site is
http://www.sec.gov.
CEL-SCI will provide, without charge, to each person to whom a copy of
this prospectus is delivered, including any beneficial owner, upon the written
or oral request of such person, a copy of any or all of the documents
incorporated by reference below (other than exhibits to these documents, unless
the exhibits are specifically incorporated by reference into this prospectus).
Requests should be directed to:
CEL-SCI Corporation
8229 Boone Blvd., #802
Vienna, Virginia 22182
(703) 506-9460
The following documents filed with the Commission by CEL-SCI (Commission
File No. 0-11503) are incorporated by reference into this prospectus:
(1) CEL-SCI's Proxy Statement relating to its March 3, 2008 shareholders'
meeting.
(2) CEL-SCI's Annual Report on Form 10-K for the fiscal year ended
September 30, 2008.
(3) CEL-SCI's report on Form 10-Q for the three months ended December 31,
2008.
All documents filed with the Commission by CEL-SCI pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to the date of this
prospectus and prior to the termination of this offering shall be deemed to be
incorporated by reference into this prospectus and to be a part of this
prospectus from the date of the filing of such documents. Any statement
contained in a document incorporated or deemed to be incorporated by reference
shall be deemed to be modified or superseded for the purposes of this prospectus
to the extent that a statement contained in this prospectus or in any
subsequently filed document which also is or is deemed to be incorporated by
reference in this prospectus modifies or supersedes such statement. Such
7
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this prospectus.
CEL-SCI has filed with the Securities and Exchange Commission a
Registration Statement under the Securities Act of l933, as amended, with
respect to the securities offered by this prospectus. This prospectus does not
contain all of the information set forth in the Registration Statement. For
further information with respect to CEL-SCI and such securities, reference is
made to the Registration Statement and to the exhibits filed with the
Registration Statement. Statements contained in this prospectus as to the
contents of any contract or other documents are summaries which are not
necessarily complete, and in each instance reference is made to the copy of such
contract or other document filed as an exhibit to the Registration Statement,
each such statement being qualified in all respects by such reference. The
Registration Statement and related exhibits may also be examined at the
Commission's internet site.
No dealer salesman or other person has been authorized to give any
information or to make any representations, other than those contained in this
prospectus. Any information or representation not contained in this prospectus
must not be relied upon as having been authorized by CEL-SCI. This prospectus
does not constitute an offer to sell, or a solicitation of an offer to buy, the
securities offered hereby in any state or other jurisdiction to any person to
whom it is unlawful to make such offer or solicitation. Neither the delivery of
this prospectus nor any sale made hereunder shall, under any circumstances,
create an implication that there has been no change in the affairs of CEL-SCI
since the date of this prospectus.